Secondary Prevention of Small Subcortical Strokes Trial
Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
Summary
The goal of this study is to learn if combination antiplatelet therapy (aspirin and
clopidogrel) is more effective than aspirin alone for the prevention of recurrent stroke and
cognitive decline, and if intensive blood pressure control is associated with fewer recurrent
strokes and cognitive decline.
On July 21, 2011 the DSMB recommended terminating the anti platelet arm of the study due to
an imbalance of overall and major non-CNS hemorrhagic SAE's and total deaths in the
investigational anti platelet combination of aspirin + clopidogrel and an interim statistical
analysis that demonstrated futility in the investigational anti platelet arm. It was
recommended that patients be continued on standard care of aspirin mono therapy until their
study close-out visit. Also, recommended the continuation and completion of the plood
pressure arm following the protocol.
Phase:
Phase 3
Details
Lead Sponsor:
University of British Columbia
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)